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Food
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FDA Rules Implementing the Bioterrorism Act of 2002 - Overview of Registration and Prior Notice Interim Final Rules
April 2004
Index of Presentation Slides
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Introduction and Background
- 1. New FDA Rules Implementing the Bioterrorism Act of 2002 - Overview of Registration and Prior Notice Interim Final Rules
- 2. Purpose of Briefing
- 3. FDA Lead Personnel
- 4. Status of Recordkeeping and Administrative Detention
- 5. Development of Registration and Prior Notice Rules
- 6. Background: FDA's Regulatory Development Timeline
- 7. Background: What Is An Interim Final Rule (IFR)?
- 8. How Do I Get a Copy of the Interim Final Rules?
- 9. How To Comment (1 of 2)
- 10. How To Comment (2 of 2)
- 11. Compliance Policy - Exercise of Enforcement Discretion
- 12. Compliance Policy (cont.)
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Registration of Food Facilities
- 13. An Overview of the Registration of Food Facilities Interim Final Rule
- 14. Bioterrorism Act of 2002 Section 305
- 15. Overview of Registration Requirements
- 16. Who Must Register?
- 17. Who Must Register? (cont.)
- 18. U.S. Agent
- 19. U.S. Agent (cont.)
- 20. What Food is Subject to FDA's Jurisdiction?
- 21. What Food is Subject to FDA's Jurisdiction (cont)?
- 22. Examples of FDA-regulated Food Within Scope of the Rule
- 23. Examples of FDA-regulated Food Within Scope of the Rule (cont.)
- 24. Registration Definitions
- 25. "Facility" Definition (cont.)
- 26. Definitions (cont.)
- 27. Definitions (cont.)
- 28. What Facilities Are Exempt?
- 29. What Facilities Are Exempt?
- 30. Definitions (cont.)
- 31. Definitions (cont.)
- 32. Definitions (cont.)
- 33. Definitions (cont.)
- 34. Definitions (cont.)
- 35. Farm Definition (cont.)
- 36. Allowable Farm Activities (If facility otherwise meets the farm definition)
- 37. Additional Exemption for Some Foreign Facilities
- 38. Foreign Facilities - Register or Exempt?
- 39. "Mixed-Type" Facilities
- 40. "Mixed-Type" Facilities (cont)
- 41. Two Types of Information: Mandatory and Optional
- 42. What Information is Required?
- 43. What Information Is Required? (cont)
- 44. What Information Is Required? (cont)
- 45. What Information is Optional?
- 46. What Information is Optional?
- 47. What Information is Optional?
- 48. How to Register
- 49. How to Register
- 50. How to Register (cont.)
- 51. Costs and Frequency of Registration
- 52. What if Changes Occur?
- 53. Cancellation of Registration
- 54. Cancellation of Registration (cont)
- 55. Where to Register, Update or Cancel a Registration
- 56.Screenshot of FDA Industry Systems Login Screen
- 57. Screenshot of FFRM Main Menu
- 58. Confidentiality of Registration Information
- 59. Registered Facilities
- 60. Food Registrations
- 61. What Are the Consequences of Failing to Register, if Required?
- 62. Consequences of Failure to Register If Required (cont)
- 63. Questions on the Registration Interim Final Rule ???
- 64. Intermission!
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Prior Notice of Imported Food
- 65. An Overview of the Prior Notice of Imported Food Interim Final Rule
- 66. Bioterrorism Act of 2002 Section 307
- 67. Overview of Prior Notice Requirements
- 68. The Current Import Process
- 69. The Current Import Process
- 70. The Current Import Process
- 71. The Current Import Process
- 72. Prior Notice of Imported Food
- 73. The New Import Process (Prior Notice)
- 74. The New Import Process (Prior Notice)
- 75. Prior Notice vs. 801(a) Admissibility
- 76. Prior Notice vs. 801(a) Admissibility (cont.)
- 77. FDA'S Prior Notice: Definitions
- 78. Port of Arrival vs. Port of Entry
- 79. FDA Country of Production (Originating Country)
- 80. FDA Country of Production vs. CBP Country of Origin
- 81. FDA'S Prior Notice: Definitions
- 82. "Article of Food" vs. Shipment of Food*
- 83. What Food Imports are Subject to Prior Notice?
- 84. What Food Imports are Subject to Prior Notice (cont)?
- 85. What Definition of "Food" Applies?
- 86. Examples of FDA-regulated Food Within Scope of the Rule
- 87. Examples of FDA-regulated Food Within Scope of the Rule
- 88. What is Excluded from the Prior Notice Food Definition
- 89. What Kinds of Food Imports are Not Subject to Prior Notice?
- 90. What Kinds of Food Imports are Not Subject to Prior Notice?
- 91. Comparison of "Food" for Registration and Prior Notice
- 92. Who is Authorized to Provide Prior Notice?
- 93. How Do I Submit Prior Notice?
- 94. Submitting Prior Notice (cont.)
- 95. Prior Notice System Interface Screenshot
- 96. Submitting Prior Notice (cont.)
- 97. Submitting Prior Notice (cont.)
- 98. When Is My Prior Notice Due?
- 99. When Is My Prior Notice Due? (cont.)
- 100. What Information is Required in a Prior Notice?
- 101. What Information is Required in a Prior Notice?
- 102. What Information is Required in a Prior Notice?
- 103. What Information is Required in a Prior Notice?
- 104. What Information is Required in a Prior Notice? (cont.)
- 105. What Information is Required in a Prior Notice? (cont.)
- 106. What Information is Required in a Prior Notice? (cont.)
- 107. Requirements for Food Arriving by International Mail
- 108. Requirements for Food Refused for Inadequate Prior Notice
- 109. What Happens When FDA Accepts Your PN For Review?
- 110. Prior Notice Confirmation Number Must Accompany . . .
- 111. What if the Information Changes After I Submit a Prior Notice?
- 112. What Happens to Food Without Adequate Prior Notice?
- 113. What Happens to Food Without Adequate Prior Notice?
- 114. What Happens to Food Without Adequate Prior Notice?
- 115. Consequences of Failure to Submit Adequate Prior Notice
- 116. Consequences of Failure to Register If Required
- 117. Consequences of Failure to Register If Required (cont.)
- 118. FDA-CBP Joint Implementation Plan
- 119. Compliance Status
- 120. Prior Notice Submission By Source
- 121. ACS Submission By Source
- 122. Percent of Information Complete
- 123. Percent Complete by Mode of Transportation (ACS)
- 124. Percent Complete by Mode of Transportation (PNSI)
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Additional Information
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